GXH — Device, Surgical, Cryogenic Class II
FDA product code GXH covers "Device, Surgical, Cryogenic", a Class II medical device regulated under 21 CFR 882.4250. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXH
- Device Class
- Class II
- Regulation Number
- 882.4250
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250371 | atricure | cryoICE cryoXT cryoablation probe (cryoXT) | April 10, 2025 |
| K243677 | pacira biosciences | iovera° System | December 26, 2024 |
| K243157 | atricure | AtriCure cryoICE BOX (ACM) | October 29, 2024 |
| K233170 | atricure | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio | October 26, 2023 |
| K220656 | pacira biosciences | iovera System | May 20, 2022 |
| K211334 | pacira pharmaceuticals | Iovera System | September 10, 2021 |
| K200697 | atricure | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoa | December 23, 2020 |
| K182565 | atricure | AtriCure cryoICE cryoSPHERE cryoablation probe | November 9, 2018 |
| K173763 | myoscience | iovera system | February 28, 2018 |
| K180138 | atricure | AtriCure cryoICE cryo-ablation probe (CRYO2) | February 15, 2018 |
| K161835 | myoscience | iovera system | March 24, 2017 |
| K142866 | myoscience | Myoscience iovera system | January 21, 2015 |
| K142203 | atricure | Atricure Cryo Module System; cryoICE cryoablation probe | November 25, 2014 |
| K133453 | myoscience | IOVERA | March 24, 2014 |
| K123516 | myoscience | CRYO-TOUCH IV | January 10, 2013 |
| K120415 | myoscience | CRYO-TOUCH III | June 22, 2012 |
| K102021 | myoscience | CRYO-TOUCH II | September 17, 2010 |
| K100447 | myoscience | MYOSCIENCE CRYO-TOUCH | June 25, 2010 |
| K050272 | cryomedical instruments | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | March 24, 2005 |
| K031482 | cryomedical instruemts | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) | July 10, 2003 |